Field of the Invention
The present disclosure relates to compositions, devices, and methods for capture of exosomes, vesicles, and other circulating membrane bound nucleic acid and/or protein-containing structures that are released from cells into biological fluids.
Description of Related Art
Currently, many diagnostic tests are performed on a biological fluid sample (e.g., blood, urine, etc.) extracted from a patient for the diagnosis or prognosis of disease. The diagnosis or prognosis may be derived from identification of a biomarker or a biochemical pattern that is not present in healthy patients or is altered from a previously obtained patient sample. However, these diagnostic tests are typically based upon the presence of known and well characterized biomarkers in the fluid sample (e.g., electrolytes, urea, creatinine, glucose, plasma proteins such as albumins, immunoglobulins and the like, biological compounds such as thiamin, riboflavin, niacin, vitamin B6 , folic acid, vitamin D, biotin, or iron). Some diagnostic tests are directed to detection of specific biomarkers (e.g., cell surface proteins) that are unique to diseased cells. Some diagnostic tests are designed to detect or identify disease states through the isolation and amplification of nucleic acids, in order to study expression levels of certain disease-associated genes.
Often, use of bodily fluids to isolate or detect biomarkers significantly dilutes a biomarker and results in readouts that lack the requisite sensitivity. Additionally, most biomarkers are produced in low or even moderate amounts in tissues other than the diseased tissue, such as normal tissues. Thus, there exists a need for improved sensitivity and accuracy in diagnostic assays that employ biological fluids such as bodily fluids.